Ruxolitinib for the Treatment of T-Cell Large Granular Lymphocytic Leukemia

T-Cell Large Granular Lymphocyte Leukemia Clinical Trial

Official title: A Phase II Study Evaluating the Efficacy of Ruxolitinib in Patients With T-Cell Large Granular Lymphocytic Leukemia (T-LGLL)

Status Recruiting

Clinical Trial Summary

This phase II trial tests whether ruxolitinib works to shrink tumors in patients with T-cell large granular lymphocyte leukemia. Ruxolitinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Clinical Trial Description

PRIMARY OBJECTIVE:

I. Determine the overall response rate (ORR) of ruxolitinib in patients with T-cell large granular lymphocytic leukemia (T-LGLL) as compared to historical controls.

SECONDARY OBJECTIVES:

I. To determine the overall response rate (complete response [CR] and partial response [PR]) of ruxolitinib in patients with T-LGLL.

II. Duration of response to ruxolitinib. III. Leukemia-free survival. IV. Rate of conversion from PR at 4 months to CR at 8 and 12 months (at full ruxolitinib dosage).

V. Rate of molecular remission (T-cell receptor [TCR] clearance, STAT3 mutation clearance) at 4, 8, 12 months.

VI. Incidence of grade III/IV toxicities (at full ruxolitinib dosage). VII. Quality of life using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-Core 30 (C30), Health Assessment Questionnaire-Disability Index (HAQDi), Short Form (SF)-36 questionnaire at baseline, after 5 months, 1 year of treatment.

EXPLORATORY OBJECTIVE:

I. Objective benefit (OB) rate at 4 months defined as a patient that had improvement in their cytopenias, transfusion dependence but not attaining a PR.

OUTLINE:

Patients receive ruxolitinib orally (PO) twice daily (BID) on days 1-28. Cycles repeat every 28 days for 12 months in the absence of disease progression or unacceptable toxicity. Patients who achieve a response (CR or PR) may receive an additional 12 months of ruxolitinib, for a maximum of 24 months. ;

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Lymphoid
• T-Cell Large Granular Lymphocyte Leukemia

• NCT number: NCT05592015
• Study type: Interventional
• Source: Ohio State University Comprehensive Cancer Center
• Contact: The Ohio State University Comprehensive Cancer Center
• Phone: 800-293-5066
• Email: OSUCCCClinicaltrials@osumc.edu
• Status: Recruiting
• Phase: Phase 2
• Start date: May 3, 2023
• Completion date: December 31, 2025